The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance giving details important for companies registering devices on the UK market. Information on UK registration procedures and rules is essential for system users as the UK moves to the UK Conformity Assessment (UKCA) after a 30-month transition period. A consultation on the UKCA marking is anticipated later in the year.
The EU CE is still valid in Great Britain until 30 June 2023. Northern Ireland stays part of the EU regarding device regulation but with MHRA supervision and special conditions applying to Great Britain based device companies that want to get into the Northern Ireland market.
The MHRA specify that, firstly, the manufacturer’s legal entity name and address, as on the device labelling/packaging, is required when registering products in the UK. In addition, manufacturers have to declare the company type i.e., limited company, sole trader etc. The manufacturer also needs to supply an administrative contact (up to 15 contacts can be named).
When it comes to UK Responsible Persons (UKRP), a letter of designation and legal contract must be presented declaring that the UKRP is representing the manufacturer solely. The letter must lay down obligatory responsibilities that are contracted to be assumed on behalf of the manufacturer.
Users also must present device details affirming:
– Class of the device to be registered;
– The Global Medicinal Devices Nomenclature (GMDN) code and term to describe the device;
– Basic UDI-DI, if applicable;
– Model or version information;
– Catalogue/reference number;
– UK approved body/EU notified body, where applicable; and
– Important features e.g., sterility, whether containing latex or MRI compatible etc. The full MHRA Manufacturer and Device and Product and Importer Attributes lists these fully.
Information on custom-made devices and registering products in Northern Ireland are included in the guidance, which also gives details on when to register a device on the Great Britain market. The timings for registration of devices in Great Britain, under the new UK system of registration that came into force on 1January 2021 are as follows:
– Straight away (no grace period), if the manufacturer is in the UK or the authorized representative (AR) is in Northern Ireland for 1) class I devices 2) custom-made devices 3) general IVDs 4) all IVDs going through performance evaluation and 5) systems and procedure packs.
– From 1 May: active implantable medical devices; class III medical devices; class IIb implantable medical devices; and IVD List A products.
– From 1 September: class IIb non-implantable medical devices; class IIa medical devices; IVD List B products; and self-test IVDs. And
– From 1 January 2022 where manufacturers have not yet earlier been required to register with the MHRA, i.e., where the manufacturer or AR is not based in the UK: class I medical devices; custom-made devices; general IVDs; and systems and procedure packs.
It is not necessary for distributors or suppliers to register with the MHRA. If the Great Britain importer is not the UKRP, the importer has to advise the relevant UKRP of its plan to import a device. The guidance reflects that the UK regulation in keeping with the EU CE marking but the regulator may want to change that at some stage. Digital health regulation is an area which could be improved as neither the EU nor the UK have an appropriate system and in this case the UK could deviate from the EU.